Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?

Not Applicable

Completed

• Conditions: Anesthesia; Orthopedic Surgery
• Interventions: Procedure: spinal anesthesia with no sedation.; Drug: Double-dose midazolam for sedation under spinal anesthesia.; Drug: single-dose midazolam for sedation under spinal anesthesia.

• Registration Number: NCT04232150
• Lead Sponsor: University of Jordan

Brief Summary

Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Detailed Description

Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The main goals of sedation for surgeries under spinal anesthesia are patient comfort, preservation of protective airway reflexes, and the help in the maintenance of hemodynamic stability during the surgical procedure. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-11-01
• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• patients undergoing total knee or total hip replacement.
• ASA I, II, or III.
• patients undergoing spinal anesthesia.

Exclusion Criteria

• patient refusal.
• <24 hours sedative administration.
• patient with hearing impairment.
• neurological or memory disorder.
• abnormal kidney function tests.
• any contraindication for spinal anesthesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C (control group)	spinal anesthesia with no sedation.	control group will receive no sedation under spinal anesthesia.
Group M (double dose group)	Double-dose midazolam for sedation under spinal anesthesia.	patients will receive 0.025mg/kg midazolam sedation twice under spinal anesthesia.
Group O (single dose group)	single-dose midazolam for sedation under spinal anesthesia.	patients will receive 0.025mg/kg midazolam sedation under spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
Postoperative recall of auditory stimuli and intraoperative noise	4 months	For auditory recall, a question was asked by the surgeon to the patient at maximum stimulation. Patients were examined for auditory recall by following-up the patients postoperatively in the inpatient department.
Postoperative recall of visual stimuli	4 months	For visual recall, a picture of a horse assigned at maximum stimulation, a cat at recovery room, and a bird after discharge to the inpatient department. Patients were examined for visual recall by following-up the patients postoperatively in the inpatient department.

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Jordan